A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

July 26, 2002

Last Updated Date

June 23, 2005

Start Date ^ICMJE

August 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00042328 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Official Title ^ICMJE

A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients

Brief Summary

The purpose of this research is to study the pharmacology (how the body handles this drug) of valacyclovir in children receiving treatment for cancer. This study will last approximately 7 days.

Detailed Description

In this study, patients will receive a single dose of oral valacyclovir. Blood samples will be drawn to evaluate the pharmacology (how the body handles the drug). Blood samples (less than one teaspoon each) will be obtained before receiving the drug and at 0.5, 1, 1.5, 2, 5, 6, and 8 hours after receiving the drug. The total amount of blood drawn from patients for all blood work including routine blood tests as well as pharmacokinetics will not be greater than 5% of the total blood volume.

We will also have all urine output collected for 8 hours starting at the time patients receive the dose of valacyclovir. A 5cc sample of urine will be collected and analyzed to determine how the body handles the drug at hours 2, 4, 6, and 8.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Neoplasms

Intervention ^ICMJE

Drug: Valacyclovir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion criteria:

Age: Patients must be > / = 2 and < / = 18 years old.
Life Expectancy: Patients must have a life expectancy of > 8 weeks
Subjects must have a diagnosed malignancy, and must currently be receiving consolidation or maintenance chemotherapy
Hepatic/Renal Function: Patients must have adequate hepatic function (bilirubin < / = 1.5 mg/dl: SGPT < 3x normal) and adequate renal function (creatinine < / = 1 mg/dl: BUN < 20 )
Medication Tolerance: Patients must be able to swallow pills or tolerate a suspension of the medication
Fluid Tolerance: Children must be able to retain liquids at the time of enrollment
Informed Consent: Written informed consent will be obtained from all patients and/or their parents prior to enrollment
Pregnancy: Women of childbearing age must have a negative serum pregnancy test at the time of study entry

Exclusion criteria:

More than one prior chemotherapy regimen.
Patients with uncontrolled infections.
Subjects with known history of adverse reaction to acyclovir in the past.
Patients with concurrent infections requiring treatment with valacyclovir or acyclovir.

Gender

Both

Ages

2 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00042328

Responsible Party

Study ID Numbers ^ICMJE

H9912, VALACYCLOVIR SINGLE DOSE

Study Sponsor ^ICMJE

Baylor College of Medicine

Collaborators ^ICMJE

Texas Children's Hospital

Investigators ^ICMJE

Principal Investigator:

Susan Blaney, MD

Texas Children's Hospital

Information Provided By

Baylor College of Medicine

Verification Date

May 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP